CLINDAMYCIN IV INFUSION SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

J01FF01

INN (Διεθνής Όνομα):

CLINDAMYCIN

Δοσολογία:

12MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

CLINDAMYCIN (CLINDAMYCIN PHOSPHATE) 12MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

50ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

LINCOMYCINS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0105830009; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2013-07-10

Αρχείο Π.Χ.Π.

_ _
_Clindamycin IV Infusion (clindamycin phosphate) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CLINDAMYCIN IV INFUSION
Clindamycin Injection in 5% Dextrose w/v
Minibags, clindamycin 12 mg/mL (600 mg/50 mL) and
18 mg/mL (900 mg/50 mL) (as clindamycin phosphate)
Sterile Solution
Antibiotic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
July 10, 2013
Date of Revision:
July 26, 2023
Submission Control Number: 272119
_ _
_Clindamycin IV Infusion (clindamycin phosphate) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage
Adjustment
07/2023
7 WARNINGS AND PRECAUTIONS, Renal
07/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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6
4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
...............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
......................................................